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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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NA - 06009544049838

Abutment Healing PKC Can E/H Ø4
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC3-EX-40
In Commercial Distribution

  • 06009544049838 ()


  • Dental implant suprastructure, temporary, preformed, single-use

NA - 06009544049821

Abutment Healing PKC Can E/H Ø3.25
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC3-EX-34
In Commercial Distribution

  • 06009544049821 ()


  • Dental implant suprastructure, temporary, preformed, single-use

NA - 06009544049791

Abutment Healing PKC Lat E/H Ø3.25
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC2-EX-34
In Commercial Distribution

  • 06009544049791 ()


  • Dental implant suprastructure, temporary, preformed, single-use

NA - 06009544049784

Abutment Healing PKC Lat E/H Ø4
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC2-EX-40
In Commercial Distribution

  • 06009544049784 ()


  • Dental implant suprastructure, temporary, preformed, single-use

NA - 06009544049777

Abutment Healing PKC Lat E/H Ø3
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC2-EX-30
In Commercial Distribution

  • 06009544049777 ()


  • Dental implant suprastructure, temporary, preformed, single-use

NA - 06009544049739

Abutment Healing PKC Cen E/H Ø4
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC1-EX-40
In Commercial Distribution

  • 06009544049739 ()


  • Dental implant suprastructure, temporary, preformed, single-use

NA - 06009544049715

Abutment Healing PKC Cen E/H Ø3
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC1-EX-30
In Commercial Distribution

  • 06009544049715 ()


  • Dental implant suprastructure, temporary, preformed, single-use

NA - 06009544049722

Abutment Healing PKC Cen E/H Ø3.25
SOUTHERN IMPLANTS (PTY) LTD
HA-PKC1-EX-34
In Commercial Distribution

  • 06009544049722 ()


  • Dental implant suprastructure, temporary, preformed, single-use

BIOSTEP LP - 00713980022312

BioStep LP, Size 25, Left, Rate E
Alps South, LLC
BSLP-25LE
In Commercial Distribution

  • 00713980022312 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980022237

BioStep LP, Size 24, Right, Rate E
Alps South, LLC
BSLP-24RE
In Commercial Distribution

  • 00713980022237 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980022152

BioStep LP, Size 24, Left, Rate E
Alps South, LLC
BSLP-24LE
In Commercial Distribution

  • 00713980022152 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980022077

BioStep LP, Size 23, Right, Rate E
Alps South, LLC
BSLP-23RE
In Commercial Distribution

  • 00713980022077 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980021995

BioStep LP, Size 23, Left, Rate E
Alps South, LLC
BSLP-23LE
In Commercial Distribution

  • 00713980021995 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980021919

BioStep LP, Size 22, Right, Rate E
Alps South, LLC
BSLP-22RE
In Commercial Distribution

  • 00713980021919 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980021834

BioStep LP, Size 22, Left, Rate E
Alps South, LLC
BSLP-22LE
In Commercial Distribution

  • 00713980021834 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980024071

BioStep LP, Size 30, Right, Rate E
Alps South, LLC
BSLP-30RE
In Commercial Distribution

  • 00713980024071 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980023913

BioStep LP, Size 30, Left, Rate E
Alps South, LLC
BSLP-30LE
In Commercial Distribution

  • 00713980023913 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980023753

BioStep LP, Size 29, Right, Rate E
Alps South, LLC
BSLP-29RE
In Commercial Distribution

  • 00713980023753 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980023593

BioStep LP, Size 29, Left, Rate E
Alps South, LLC
BSLP-29LE
In Commercial Distribution

  • 00713980023593 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980023432

BioStep LP, Size 28, Right, Rate E
Alps South, LLC
BSLP-28RE
In Commercial Distribution

  • 00713980023432 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980023272

BioStep LP, Size 28, Left, Rate E
Alps South, LLC
BSLP-28LE
In Commercial Distribution

  • 00713980023272 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980023111

BioStep LP, Size 27, Right, Rate E
Alps South, LLC
BSLP-27RE
In Commercial Distribution

  • 00713980023111 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980022954

BioStep LP, Size 27, Left, Rate E
Alps South, LLC
BSLP-27LE
In Commercial Distribution

  • 00713980022954 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980022794

BioStep LP, Size 26, Right, Rate E
Alps South, LLC
BSLP-26RE
In Commercial Distribution

  • 00713980022794 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980022633

BioStep LP, Size 26, Left, Rate E
Alps South, LLC
BSLP-26LE
In Commercial Distribution

  • 00713980022633 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980022473

BioStep LP, Size 25, Right, Rate E
Alps South, LLC
BSLP-25RE
In Commercial Distribution

  • 00713980022473 ()


  • Mechanical-resistance external ankle-foot prosthesis

n/a - 00874750007967

MOD 2200 .125OD I/E,4MMOD MPT
HANS RUDOLPH, INC.
2200
Not in Commercial Distribution

  • 00874750007967 ()
P0355

  • Non-rebreathing valve, reusable

N/A - 00681490038263

INSERTER 1352237 E/Z LOAD T TUBE
MEDTRONIC XOMED, INC.
1352237
In Commercial Distribution

  • 00681490038263 ()


  • Tympanostomy tube inserter, reusable

IMS - 10889950055790

8 Inst. Sig Cass Gray LP, E
HU-FRIEDY MFG. CO., LLC
IM5081LPE
Not in Commercial Distribution

  • 10889950055790 ()
IM5081LPE

  • Device sterilization/disinfection container, reusable

A Plus - 00683534080061

COVERALL, E/W&A, COLLAR;WHITE, XXXL
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080067 ()
  • 00683534080061 ()
68-601W-Z

  • Patient gown, single-use

IMS - 10889950060688

SPECIAL 6.5 X 10.5, ORANGE, 2 E
HU-FRIEDY MFG. CO., LLC
IM8123E2
In Commercial Distribution

  • 10889950060688 ()
IM8123E2

  • Device sterilization/disinfection container, reusable

IMS - 10889950060411

SPECIAL 6.5 X 10.5, GRAY, 2 E
HU-FRIEDY MFG. CO., LLC
IM8121E2
In Commercial Distribution

  • 10889950060411 ()
IM8121E2

  • Device sterilization/disinfection container, reusable

IMS - 10889950060237

SPECIAL 6.5 X 10.5, RED, 2 E
HU-FRIEDY MFG. CO., LLC
IM8120E2
In Commercial Distribution

  • 10889950060237 ()
IM8120E2

  • Device sterilization/disinfection container, reusable

A Plus - 00683534080054

COVERALL, E/W&A, COLLAR;WHITE, XXL
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080050 ()
  • 00683534080054 ()
68-601W-Y

  • Patient gown, single-use

A Plus - 00683534080047

COVERALL, E/W&A, COLLAR;WHITE, XL
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080043 ()
  • 00683534080047 ()
68-601W-X

  • Patient gown, single-use

A Plus - 00683534080030

COVERALL, E/W&A, COLLAR;WHITE, S
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080036 ()
  • 00683534080030 ()
68-601W-S

  • Patient gown, single-use

A Plus - 00683534080023

COVERALL, E/W&A, COLLAR;WHITE, M
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080029 ()
  • 00683534080023 ()
68-601W-M

  • Patient gown, single-use

A Plus - 00683534080016

COVERALL, E/W&A, COLLAR;WHITE, L
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 70683534080015 ()
  • 00683534080016 ()
68-601W-L

  • Patient gown, single-use

Hu-Friedy MFG Co., LLC - 10889950025328

NEVI SCALER POSTERIOR D/E, #7 HDL
HU-FRIEDY MFG. CO., LLC
SCNEVI27
In Commercial Distribution

  • 10889950025328 ()


  • Manual dental scaler, reusable

Hu-Friedy MFG Co., LLC - 10889950025311

NEVI Scaler Posterior D/E Satin Steel
HU-FRIEDY MFG. CO., LLC
SCNEVI2
In Commercial Distribution

  • 10889950025311 ()


  • Manual dental scaler, reusable

Hu-Friedy MFG Co., LLC - 10889950025250

NEVI SCALER ANTERIOR D/E #7 Hdl
HU-FRIEDY MFG. CO., LLC
SCNEVI17
In Commercial Distribution

  • 10889950025250 ()


  • Manual dental scaler, reusable

Hu-Friedy MFG Co., LLC - 10889950025243

NEVI Scaler Anterior D/E Satin Steel
HU-FRIEDY MFG. CO., LLC
SCNEVI1
In Commercial Distribution

  • 10889950025243 ()


  • Manual dental scaler, reusable

Responsive Respiratory, Inc. - 00851440007407

Single D/E Oxygen Cylinder Wheelchair Bracket
RESPONSIVE RESPIRATORY, INC.
150-0110
In Commercial Distribution

  • 00851440007407 ()


  • Wheelchair medical gas supply holder

Responsive Respiratory, Inc. - 00851440007124

D/E Dual Oxygen Cylinder Wheelchair Case
RESPONSIVE RESPIRATORY, INC.
150-1162
In Commercial Distribution

  • 00851440007124 ()


  • Gas cylinder holder

Responsive Respiratory, Inc. - 00851440007834

Single D/E Oxygen Cylinder Wheelchair Bracket
RESPONSIVE RESPIRATORY, INC.
150-0110
In Commercial Distribution

  • 00851440007834 ()


  • Wheelchair medical gas supply holder

SmartFrame - 00850359007072

SMARTFrame XG TwistPoint Kit w/ HC - E
Clearpoint Neuro, Inc.
CP-NGS-11-HC-TP32-E
Not in Commercial Distribution

  • 00850359007072 ()
CP-NGS-11-HC-TP32-E

  • Neurological stereotactic surgery system

Widex - 05706069839944

HA EJY E-PA E22 E 220 DEBLU
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839944 ()
10989662

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839937

HA EJY E-PA E22 E 220 ATBG
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839937 ()
10989661

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839920

HA EJY E-PA E22 E 220 TMGR
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839920 ()
10989660

  • Air-conduction hearing aid, receiver-in-canal

Widex - 05706069839913

HA EJY E-PA E22 E 220 SLVGR
Widex A/S
ENJOY E-PA 220
In Commercial Distribution

  • 05706069839913 ()
10989659

  • Air-conduction hearing aid, receiver-in-canal
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